Data di Pubblicazione:
2021
Abstract:
BACKGROUND The appropriate duration of dual antiplatelet therapy in patients at high risk for bleeding after the implantation of a drug-eluting coronary stent remains unclear. METHODS One month after they had undergone implantation of a biodegradable-polymer sirolimus-eluting coronary stent, we randomly assigned patients at high bleeding risk to discontinue dual antiplatelet therapy immediately (abbreviated therapy) or to continue it for at least 2 additional months (standard therapy). The three ranked primary outcomes were net adverse clinical events (a composite of death from any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (a composite of death from any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding; cumulative incidences were assessed at 335 days. The first two outcomes were assessed for noninferiority in the per-protocol population, and the third outcome for superiority in the intention-to-treat population. RESULTS Among the 4434 patients in the per-protocol population, net adverse clinical events occurred in 165 patients (7.5%) in the abbreviated-therapy group and in 172 (7.7%) in the standard-therapy group (difference, -0.23 percentage points; 95% confidence interval [CI], -1.80 to 1.33; P<0.001 for noninferiority). A total of 133 patients (6.1%) in the abbreviated-therapy group and 132 patients (5.9%) in the standard-therapy group had a major adverse cardiac or cerebral event (difference, 0.11 percentage points; 95% CI, -1.29 to 1.51; P=0.001 for noninferiority). Among the 4579 patients in the intention-to-treat population, major or clinically relevant nonmajor bleeding occurred in 148 patients (6.5%) in the abbreviated-therapy group and in 211 (9.4%) in the standard-therapy group (difference, -2.82 percentage points; 95% CI, -4.40 to -1.24; P<0.001 for superiority). CONCLUSIONS One month of dual antiplatelet therapy was noninferior to the continuation of therapy for at least 2 additional months with regard to the occurrence of net adverse clinical events and major adverse cardiac or cerebral events; abbreviated therapy also resulted in a lower incidence of major or clinically relevant nonmajor bleeding.
Tipologia CRIS:
14.a.1 Articolo su rivista
Keywords:
Acute Coronary Syndrome; Aged; Cardiovascular Diseases; Drug Therapy, Combination; Drug-Eluting Stents; Female; Hemorrhage; Humans; Kaplan-Meier Estimate; Male; Myocardial Infarction; Platelet Aggregation Inhibitors; Risk Factors; Stroke; Thrombosis; Percutaneous Coronary Intervention
Elenco autori:
Valgimigli, Marco; Frigoli, Enrico; Heg, Dik; Tijssen, Jan; Jüni, Peter; Vranckx, Pascal; Ozaki, Yukio; Morice, Marie-Claude; Chevalier, Bernard; Onuma, Yoshinobu; Windecker, Stephan; Tonino, Pim A L; Roffi, Marco; Lesiak, Maciej; Mahfoud, Felix; Bartunek, Jozef; Hildick-Smith, David; Colombo, Antonio; Stanković, Goran; Iñiguez, Andrés; Schultz, Carl; Kornowski, Ran; Ong, Paul J L; Alasnag, Mirvat; Rodriguez, Alfredo E; Moschovitis, Aris; Laanmets, Peep; Donahue, Michael; Leonardi, Sergio; Smits, Pieter C; Valgimigli, M; C Smits, P; A Van Es, G; G B W, E Vos; Spitzer, E; Vrancks, P; Chevalier, B; Ozaki, Y; C Morice, M; Windecker, S; Onuma, Y; Frigoli, E; Frenk, A; Jüni, P; Tijssen, J; Paunovic, D; S Ajit, M; Alasnag, M; Bartunek, J; Colombo, A; Hildick-Smith, D; Iñiguez, A; Mahfoud, F; Kornowski, R; Lesiak, M; J Ong, P; E Rodriguez, A; Roffi, M; Schultz, C; Stankovic, G; Tonino, P; Moschovitis, Aris; Laanmets, Peep; Donahue, Michael; Bertrand, M; Pocock, S; Urban, P; Leonardi, S; Hanet, C; Lopes, R; P McFadden, E; Radke, P; O Roine, R; Ladan, Boudijn; Laura van der Waal, ; Engelbrecht, Yvonne; Paddenburg, Fred; Ren, Ben; Ingrid de Zwart, ; Elshout, Liliane; Jonk, Judith; Rademaker-Havinga, Tessa; Ria van Vliet, ; Phani Krishna Kondamudi, ; Morsiani, Laure; Windhövel, Ute; Anita van der Wal, ; Bakker, Chantal; Minagawa, Kazuhiro; Mieres, Juan; Cura, Fernando; Fernandez-Pereira, Carlos; Lee, Astin; Jepson, Nigel; Whitbourn, Robert; Owen Christopher Raffel, ; Huber, Kurt; Weidinger, Franz; Fazila-Tun-Nesa Malik Hasselt, ; Ziekenhuis, Jessa; Vranckx, Pascal; Ziekenhuis, Imelda; Dewilde, Willem; Aminian, Adel; Aalst, Emanuele; Pourbai, Suzanne; Xaplanteris, Panagiotis; Velchev, Vasil; Karageorgiev, Dimitar; Mateev, Hristo; Gelev, Valeri; Kala, Petr; Mates, Martin; Kelbæk, Henning; Hovasse, Thomas; Delorme, Laurent; Cuisset, Thomas; Belle, Loïc; Beygui, Farzin; Piot, Christophe; Jean François Morelle, ; Koning, Rene; Valla, Mathieu; Brunel, Philippe; Cayla, Guillaume; Teiger, Emmanuel; Montalescot, Gilles; Spaulding, Christian; Guyon, Phillipe; Stylianos, Pyxaras; Merkely, B; Ungi, Imre; Rajpal, K Abhaichand; Atul Damodar Abhyankar, ; Sengottuvelu, G; Majdi, Halabi; Roguin, Ariel; Feld, Yair; Lotan, Chaim; Garducci, Stefano; Reimers, Bernhard; Sardella, Gennaro; Milan, Antonio; Chieffo, Alaide; Tamburino, Corrado; Andò, Giuseppe; Testa, Luca; Maurizio Di Biasi, ; Sciahbasi, Alessandro; Calabro, Paolo; Minervini, Gianluigi; Loi, Bruno; Fabbiocchi, Franco; Oreglia, Jacopo; Sganzerla, Paolo; Ozaki, Yukio; Ando, Kenji; Higuchi, Yoshiharu; Nanasato, Mamoru; Ishibashi, Yuki; Matsuo, Hitoshi; Yoshida, Ruka; Shimizu, Kiyokazu; Kamiya, Haruo; Komiyama, Nobuyuki; Amano, Tetsuya; Murohara, Toyoaki; Yamazaki, Seiji; Noor, Husam; Kedev, Sasko; Podolec, Jakub; Reszuch, Krzysztof; Wlodarczak, Adrian; Dudek, Dariusz; Pedro Canas da Silva, ; Mangovski, Ljupco; Topic, Dragan; Debeijacki, Dragan; Paul Ong Jau Lueng, ; Syed Saqib Imran, ; Seung-Jung, Park; Jose Francisco Diaz Fernandez, ; Brudo Garcia Del Blanco, ; Mainar, Vicente; Ivan Gomez Blazquez, ; Pinar, Eduardo; Javier Escaned Barbosa, ; Antoni, Joan; Sainz, Fermin; Goicolea, Javier; Fröbert, Ole; Kastberg, Robert; Leibundgut, Gregor; Pedrazzini, Giovanni; Garachemani, Ali; Siegrist, Patrick; Cook, Stephane; Mafragi, Al; Jessurun, G; Ruifrok, W; Danse, Peter; Polad, J; Kauer, Floris; Clemens von Birgelen, ; Jurrien Ten Berg, ; Ijsselmuiden, Sander; Somi, Samer; Johnson, Tom; Routledge, Helen; Din, Jehangir; Munir, Shahzad; Mcdonald, John; Kikreja, Neville; Mamas, Mamas; Das, Rajiv; Contractor, Hussain; Peace, Aaron; Williams, Rupert; Nguyen Ngoc Quang,
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